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to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
Some authors have also advocated the use of activity restriction in women with arrested PTL to reduce the risk of PTB. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. So far, the benefit of activity restriction in women with arrested PTL is still subject of debate and no Randomized Controlled Trial (RCT) has been undertaken.
Thus, the aim of this trial is to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity restriction | Experimental | Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended. |
|
| No activity restriction | No Intervention | Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity restriction | Behavioral | Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended. |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth | Preterm delivery at less than 37 weeks of gestation | 37 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean gestational age at delivery in weeks | Mean gestational age at delivery in weeks | At the time of delivery |
| Mean latency | from randomization to delivery |
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Inclusion Criteria:
Exclusion Criteria:
only pregnant women (limit to Female)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giuseppe De Placido | Recruiting | Naples | 80129 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37080296 | Derived | Saccone G, Della Corte L, Cuomo L, Reppuccia S, Murolo C, Napoli FD, Locci M, Bifulco G. Activity restriction for women with arrested preterm labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100954. doi: 10.1016/j.ajogmf.2023.100954. Epub 2023 Apr 18. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial
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|
| from randomization to delivery |
| admission to nicu | number of babies admitted to neonatal intensive care unit | at the time of delivery until 28 days of life |
| neonatal death | death of a live-born baby | at the time of delivery until 28 days of life |
| a composite of adverse perinatal outcome | defined as at least one of the following:
| at the time of delivery until 28 days of life |
| chorioamnionitis | diagnosis of choriamnionitis at histological examination of the placenta. | at the time of delivery |
| D000091642 | Urogenital Diseases |